On May 21, 2024 Indapta Therapeutics, Inc., a privately held biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and autoimmune diseases, reported that Cancer Prevention and Research Institute of Texas (CPRIT) has granted the company a competitive product development research award (Press release, Indapta Therapeutics, MAY 21, 2024, View Source [SID1234643513]). The $4.5 million grant will support Indapta’s ongoing clinical development of its lead product, IDP-023, for patients with advanced non-Hodgkin’s lymphoma and multiple myeloma.

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"We greatly appreciate that CPRIT has recognized the promise of Indapta’s allogeneic g-NK cell therapy for the treatment of advanced cancer patients," said Dr. Mark Frohlich, CEO of Indapta. "We are highly encouraged to be seeing early evidence of clinical activity in the safety run-in portion of the trial at the lowest cell dose and without the addition of a monoclonal antibody. We look forward to using the CPRIT funds to treat additional patients in order to reach clinical proof-of-concept in our Phase 1 dose escalation trial."

Patients enrolled in the Phase I clinical trial to date have received up to three planned doses of IDP-023 with or without interleukin-2. Once safety of multiple doses in combination with interleukin-2 has been established, cohorts of patients with lymphoma and multiple myeloma will receive escalating doses of IDP-023 in combination with the monoclonal antibodies, rituximab and daratumumab, respectively.

Indapta’s Differentiated g-NK Cell Therapy

Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as "g minus" NK cells, or "g-NK" cells. G‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability. IDP-023 has several differentiated mechanisms of killing target cells without the need for genetic engineering, including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells.

Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, View Source)

Based on evidence that endogenous g-NK cells are protective against the development of multiple sclerosis, as well as slow disease progression in patients with multiple sclerosis, Indapta plans to file an IND in Q3 to initiate a clinical trial of g-NK cells in patients with multiple sclerosis.

On May 21, 2024 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, reported the completed acquisition of its Founded Entity, Karuna Therapeutics, Inc. ("Karuna"), by Bristol Myers Squibb (NYSE: BMY) ("BMS"), which has acquired all outstanding common stock of Karuna for $330.00 per share, for a total equity value of approximately $14 billion (Press release, Bristol-Myers Squibb, MAY 21, 2024, View Source [SID1234643494]).

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"This acquisition recognizes the enormous potential of KarXT to help millions of people with schizophrenia in need of a new therapeutic option, and BMS will provide the global leadership to maximize the reach of KarXT," said Eric Elenko, Ph.D., Chief Innovation Officer at PureTech, and a co-inventor of KarXT. "This is also an important milestone for PureTech, where KarXT was invented, and for Karuna, one of our Founded Entities advancing innovative therapeutic approaches on the basis of validated mechanisms. We congratulate the Karuna and BMS teams on the completion of their transaction, and we wish them success in their joint pursuit to make a difference for people living with psychiatric and neurological conditions."

If approved, KarXT will represent the first new mechanism of action for patients with schizophrenia in over 50 years.

As of February 15, 2024, PureTech’s percentage ownership in Karuna was approximately 2.3% on an outstanding voting share basis, resulting in an estimated $293 million in gross proceeds to PureTech upon the close of the transaction. PureTech directed approximately $18.5 million towards the founding and development of Karuna, and following the close of the BMS acquisition will have generated approximately $1.1 billion in direct cash proceeds to PureTech. Under its license agreement with Karuna, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals. PureTech is also owed certain royalties on net sales and is eligible to receive up to $400 million in milestone payments under its agreement with Royalty Pharma1.

The full text of the announcement from Bristol Myers Squibb is as follows:

Bristol Myers Squibb Completes Acquisition of Karuna Therapeutics, Strengthening Neuroscience

1
As of March 22, 2023, PureTech has sold its right to receive a 3% royalty from Karuna to Royalty Pharma on net sales up to $2 billion annually, after which threshold PureTech will receive 67% of the royalty payments and Royalty Pharma will receive 33%.

KarXT, Karuna’s Lead Asset, Is a Potential First-in-Class Treatment for Schizophrenia with Multi-Billion Dollar Sales Potential Across Multiple Indications

PRINCETON, N.J.— Bristol Myers Squibb (NYSE: BMY) reported that it has successfully completed its acquisition of Karuna Therapeutics, Inc. ("Karuna"). With the acquisition’s completion, Karuna shares have ceased trading on the Nasdaq Global Select Market and Karuna is now a wholly owned subsidiary of Bristol Myers Squibb ("BMS").

"We are excited to expand our neuroscience portfolio as we welcome Karuna to Bristol Myers Squibb," said Chris Boerner, Ph.D., Chief Executive Officer, Bristol Myers Squibb. "Importantly, this transaction aligns with our commitment to strengthening BMS’s growth profile in the latter half of the decade and beyond. We look forward to working with Karuna’s talented team to bring KarXT to patients with schizophrenia later this year."

Through this transaction, BMS has added KarXT (xanomeline-trospium), an antipsychotic with a novel mechanism of action and a differentiated efficacy and safety profile, and Karuna’s early-stage and pre-clinical pipeline. KarXT has a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024 for the treatment of schizophrenia in adults. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease, with potential to expand to additional indications, including Bipolar I disorder and Alzheimer’s disease agitation.

As previously disclosed, the transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.30 in 2024 from the financing cost of the transaction, which is primarily from a recently completed new debt issuance. Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued disciplined resource allocation, cost efficiencies and portfolio prioritization. Bristol Myers Squibb’s cash flows and strong financial profile enable continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases.

The transaction will be accounted for as an asset acquisition resulting in an approximately $12 billion one-time, non-deductible Acquired In-Process Research and Development (Acquired IPR&D) charge impacting both 2024 first quarter and full-year GAAP and non-GAAP EPS by approximately $5.93.

Consistent with past practice, Bristol Myers Squibb generally provides updates to its financial outlook once each quarter. When considering Bristol Myers Squibb’s financial outlook issued on February 2, 2024, investors and analysts should take into account the impacts outlined above. Bristol Myers Squibb will provide an update to its financial outlook when it reports first quarter 2024 results on April 25, 2024.

Advisors

Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as exclusive financial advisor to Karuna, and Simpson Thacher & Bartlett LLP is serving as legal counsel.

On May 21, 2024 Incyte (Nasdaq:INCY) reported that it will present at the Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024 at 8:00 a.m. (EDT) in Miami (Press release, Incyte, MAY 21, 2024, View Source [SID1234643514]).

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On May 21, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the three months ended March 31, 2024 (Press release, Purple Biotech, MAY 21, 2024, View Source [SID1234643496]).

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"We look forward to presenting compelling interim Phase 2 CM24 data for the treatment of pancreatic cancer at ASCO (Free ASCO Whitepaper) 2024, where we were selected for a Late Breaking Abstract presentation. These data suggest an exciting medical direction, demonstrating potentially reduced risk of disease progression and death in a very difficult to treat indication. Following the announcement of interim results at ASCO (Free ASCO Whitepaper) on June 1, 2024, we expect to present topline data before the end of year; these clinical milestones will potentially mark significant catalysts for the value of our development pipeline," stated Gil Efron, Chief Executive Officer of Purple Biotech. "We also continue to make solid progress on NT219, which is headed into a Phase 2 trial in head and neck cancer, as well as on our tri-specific antibody platform following a Pre-IND meeting with the FDA that provided a clear path forward for our development plan through Phase 1."

Q1 2024 and Recent Clinical & Corporate Highlights:

● CM24 Pancreatic Cancer Study Selected for Late Breaking Abstract Poster Presentation at ASCO (Free ASCO Whitepaper) 2024

● Interim data suggest reduced risk of progression or death in the CM24/nivolumab plus standard of care Nal-IRI/5FU/LV arm of the study supported by higher overall response rate (ORR) and disease control rate (DCR) and decreasing CA19-9 in the experimental arm. Full interim data have been submitted to the ASCO (Free ASCO Whitepaper) Meeting.

● Interim data to be announced on June 1, 2024 in conjunction with the ASCO (Free ASCO Whitepaper) presentation

● Topline data expected Q4 2024

The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) selected Purple Biotech’s poster titled "Interim results of the Randomized Phase 2 Cohort of Study FW-2020-01 Assessing the Efficacy, Safety and Pharmacodynamics of CM24 in combination with Nivolumab and Chemotherapy in Advanced/metastatic Pancreatic Cancer" for a Late Breaking presentation at ASCO (Free ASCO Whitepaper)’s 2024 Annual Meeting.

The Phase 2 study is evaluating CM24 in combination with Bristol Myers Squibb’s PD-1 inhibitor nivolumab plus standard of care (SoC) chemotherapy in second line pancreatic ductal adenocarcinoma (PDAC) patients compared to SoC chemotherapy alone. The experimental arms of the study dosed patients with CM24 plus nivolumab and one of two SoC chemotherapies, gemcitabine/nab-paclitaxel or Nal-IRI/5FU/LV, while the control arms dosed with either respective chemotherapy alone. Approximately 60 patients have been enrolled in the randomized study across 18 centers in the U.S., Spain and Israel. Data from the gemcitabine/nab-paclitaxel arm is not yet mature for analysis.

● Phase 2 study of NT219 in combination with cetuximab as a 2nd Line treatment for R/M SCCHN is planned to commence in 2024.

● NT219 Positive Efficacy Data in Head & Neck Cancer Presented at ESMO (Free ESMO Whitepaper)-TAT 2024.

● Posters presented at AACR (Free AACR Whitepaper) 2024 demonstrated NT219’s efficacy in suppressing cancer stem cells, overcoming resistance to KRAS inhibitors and potential biomarkers for NT219 therapy.

● Established Head & Neck Cancer Scientific Advisory Board.

In a presentation at ESMO (Free ESMO Whitepaper)-TAT 2024, NT219 in combination with cetuximab demonstrated safety and early activity in patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) with dose-proportional PK values. Of the 7 evaluable R/M SCCHN patients treated at the maximum doses of 50 and 100mg/kg in which anti-tumor activity was observed, the tumor objective response rate (ORR) was 29% and the disease control rate (DCR) was 71%, both highly encouraging results. 100mg/kg was determined to be the recommended Phase 2 dose for NT219 in combination with cetuximab in the treatment of R/M SCCHN.

Key findings were shared in two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024 annual meeting in San Diego, California. NT219 was found to significantly suppress cancer stem cells, suggesting a novel therapy and new mechanism to combat cancer recurrence and overcoming resistance to KRAS(G12C) and KRAS(G12D) inhibitors in NSCLC and PDAC cells, respectively. NT219 reverses acquired resistance to KRAS inhibitors by addressing both cellular escape pathways and cancer stem cell mechanisms. Potential biomarkers for NT219 therapy were presented in an additional poster at AACR (Free AACR Whitepaper) 2024, and on-target effects of the therapy were demonstrated in patients’ tumors. Analysis of patients’ biopsies pre-treatment suggests activated IGF1R and STAT3 as potential biomarkers for this therapy.

In preparation for its upcoming Phase 2 trial of NT219, Purple Biotech convened a Scientific Advisory Board (SAB) specifically focused on the R/M SCCHN indication. The SAB is comprised of head and neck cancer key opinion leaders including oncologists, researchers, and investigators. The SAB has provided valuable guidance on clinical studies for NT219 in combination with cetuximab as a second/third line treatment and potentially in combination with a PD1 inhibitor as a first line treatment.

● Proof of Concept Achieved for Tri-Specific Antibody Platform Technology

o Platform has potential to produce a pipeline of promising drug candidates across numerous solid cancer tumors

o Lead asset, IM1240, expected to be ready for Phase 1 study by early 2026

Purple Biotech’s tri-specific platform is a T cell engager via the anti-CD3 arm, and an NK cell engager via the anti-NKG2A arm, which also functions as an important immune checkpoint inhibitor of both NK cells and specific subsets of T cells; this tri-specific approach unleashes both innate and adaptive immune systems against the tumor. Preclinical studies demonstrated an anti-tumor response and synergistic effects of the NK cell engager with the conditionally-activated T cell engager. The tri-body platform’s cleavable capping technology confines therapeutic activity to the local tumor micro environment, which increases the anticipated therapeutic window in patients.

Financial Results for the Quarter Ended March 31, 2024

Research and Development Expenses were $3.4 million for the three months ended March 31, 2024, a decrease of $0.1 million, or 2.8%, compared to $3.5 million in the same period of 2023.

Sales, General and Administrative Expenses were $1 million for the three months ended March 31, 2024, compared to $1.6 million in the same period of 2023, a decrease of $0.6 million.

Operating Loss was $4.5 million for the three months ended March 31, 2024, a decrease of $0.6 million, or 11.8%, compared to $5.1 million in the same period of 2023, mainly due to the decrease in the sales, general, and administrative expenses.

Adjusted Operating Loss (as reconciled below) was $4.2 million for the three months ended March 31, 2024, a decrease of $0.2 million, compared to $4.4 million in the same period of 2023.

Net Loss was $3.8 million, or $0.14 per basic and diluted ADS for the three months ended March 31, 2024, compared to a net loss of $4.9 million, or $0.25 per basic and diluted ADS, in the same period of 2023. The decrease in net loss was mainly due to a decrease of $0.6 million in operating expenses and an increase of $0.5 million in finance income, net.

Adjusted Net Loss (as reconciled below) for the three months ended March 31, 2024, was $4.1 million, a decrease from $4.2 million in the first three months ended March 31, 2023.

As of March 31, 2024, Purple Biotech had cash and cash equivalents and short-term deposits of $10.8 million. This cash position provides a cash runway into the first quarter of 2025.

During the three months ended March 31, 2024, the Company sold, under the Open Market Sale AgreementSM with Jefferies LLC, approximately 504,000 ADSs, at an average price of $0.742 per ADS. Net proceeds to the Company were approximately $358,000, net of issuance expenses.

Non-IFRS Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including adjusted operating loss and adjusted net loss. These non-IFRS measures are not based on any standardized methodology prescribed by IFRS and are not necessarily comparable to similar measures presented by other companies. Adjusted operating loss and adjusted net loss adjust for share-based compensation expenses. The Company’s management and board of directors utilize these non-IFRS financial measures to evaluate the Company’s performance. The Company provides these non- IFRS measures of the Company’s performance to investors because its management believes that these non- IFRS financial measures, when viewed with the Company’s results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non- IFRS measures are not measures of financial performance under IFRS and, accordingly, should not be considered as alternatives to IFRS measures as indicators of operating performance. Further, these non-IFRS measures should not be considered measures of the Company’s liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release.

On May 21, 2024 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its oncology portfolio with more than 45 abstracts in multiple cancers at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Scientific Program (#ASCO24) (Press release, Daiichi Sankyo, MAY 21, 2024, https://www.businesswire.com/news/home/20240520281085/en/Daiichi-Sankyo-Highlights-Progress-in-Creating-New-Standards-of-Care-for-Patients-Across-Multiple-Cancers-at-ASCO [SID1234643515]).

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Data at ASCO (Free ASCO Whitepaper) showcasing the company’s progress in creating new standards of care for patients with cancer will include the late-breaking positive results of the DESTINY-Breast06 phase 3 trial (LBA #1000) evaluating ENHERTU (trastuzumab deruxtecan) compared to standard of care chemotherapy in patients with HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow [defined as IHC 0 with membrane staining; IHC >0 <1+] metastatic breast cancer following one or more lines of endocrine therapy. Data from DESTINY-Breast06 will be featured in an ASCO (Free ASCO Whitepaper) press briefing.

"Results to be shared at ASCO (Free ASCO Whitepaper) from DESTINY-Breast06 demonstrate how ENHERTU continues to challenge the traditional classification and treatment of breast cancer, building on the practice-changing results seen with DESTINY-Breast04," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These significant data along with updated survival results from DESTINY-Breast03 highlight how ENHERTU is a transformative medicine for the treatment of certain patients with metastatic breast cancer."

Updated survival results from the DESTINY-Breast03 phase 3 trial (#1025) of ENHERTU versus trastuzumab emtansine (T-DM1) in patients with previously treated HER2 positive metastatic breast cancer along with interim results from the dose expansion portion of DESTINY-Breast07 phase 1b/2 trial (#1009) evaluating ENHERTU monotherapy as well as ENHERTU plus pertuzumab in patients with previously untreated HER2 positive metastatic breast cancer also will be presented.

Additional ENHERTU data at ASCO (Free ASCO Whitepaper) includes the final results of the DESTINY-Lung02 phase 2 trial (#8543) in patients with previously treated HER2 mutant non-small cell lung cancer (NSCLC) as well as three sub-analyses from the DESTINY-PanTumor02 phase 2 trial in patients with HER2 expressing metastatic biliary tract and pancreatic cancer (#4090), bladder cancer (#4565) and head and neck cancer (#6037). Data from DESTINY-PanTumor02 was one of three phase 2 trials that led to the recent accelerated approval in the U.S. of ENHERTU for a tumor agnostic indication in unresectable or metastatic HER2 positive (IHC 3+) solid tumors.

Additional Data and Trials-in-Progress Across Daiichi Sankyo’s DXd ADC Portfolio at ASCO (Free ASCO Whitepaper)
Additional sub-analyses from the TROPION-Lung02 phase 1b trial (#8617) evaluating datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy as a first-line treatment for patients with advanced or metastatic NSCLC, the intracranial efficacy of datopotamab deruxtecan in patients with advanced or metastatic NSCLC with actionable genomic alterations from the TROPION-Lung05 phase 2 trial (#8593), and patient reported outcomes from the TROPION-Breast01 phase 3 trial (#1006) of datopotamab deruxtecan versus chemotherapy in patients with previously treated inoperable or metastatic hormone receptor positive, HER2 negative breast cancer will be presented.

Trials-in-progress presentations include the IDeate-Lung02 phase 3 trial (TPS8126) evaluating ifinatamab deruxtecan (I-DXd) in patients with relapsed small cell lung cancer, the REJOICE-Ovarian01 phase 2/3 trial (TPS5625) evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer, the HERTHENA-PanTumor01 phase 2 trial (TPS3164) evaluating patritumab deruxtecan (HER3-DXd) in patients with locally advanced or metastatic solid tumors, and the first-in-human phase 1/2 trial (TPS3165) of DS-3939 in patients with advanced solid tumors.

Additional trials-in-progress featuring combinations of Daiichi Sankyo’s DXd ADCs and a novel medicine in development include a phase 1b trial (TPS4180) evaluating valemetostat, a dual inhibitor of EZH1 and EZH2, in combination with ENHERTU or datopotamab deruxtecan in patients with solid tumors and a phase 1b trial (TPS1120) evaluating valemetostat in combination with ENHERTU in HER2 low, ultralow and null metastatic breast cancers.

Daiichi Sankyo will hold a virtual conference call for investors on Monday, June 3, 2024 from 6:00 to 7:00 pm CDT / Tuesday, June 4, 2024 from 8:00 to 9:00 am JST. Executives from Daiichi Sankyo will provide an overview of the ASCO (Free ASCO Whitepaper) research data and address questions.

Highlights of data from Daiichi Sankyo’s oncology portfolio at ASCO (Free ASCO Whitepaper) 2024 include:

Presentation Title

Author

Abstract

Presentation (CDT)

ENHERTU (trastuzumab deruxtecan; T-DXd)

Breast

Trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2) low or HER2 ultralow metastatic breast cancer (mBC) with prior endocrine therapy (ET): primary results from DESTINY-Breast06 (DB-06)

G. Curigliano

LBA1000

Oral Presentation

Sunday, June 2

7:30 – 8:00 am

Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients with HER2+ mBC: updated survival results of DESTINY-Breast03

E. Hamilton

1025

Poster Session

Sunday, June 2

9:00 am – 12:00 pm

DESTINY-Breast07: dose-expansion interim analysis of T-DXd monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ mBC

F. Andre

1009

Oral Presentation

Saturday, June 1

3:00 – 6:00 pm

Pooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients with HER2+ mBC from DESTINY-Breast-01, 02, and 03

C. Saura

1023

Poster Session

Sunday, June 2

9:00 am – 12:00 pm

Lung

Trastuzumab deruxtecan in patients with HER2 mutant metastatic non-small cell lung cancer: final analysis results of DESTINY-Lung02

P. Janne

8543

Poster Session

Monday, June 3

1:30 – 4:30 pm

Tumor Agnostic

Trastuzumab deruxtecan (T-DXd) in patients with HER2 expressing biliary tract cancer and pancreatic cancer: outcomes from DESTINY-PanTumor02

D. Oh

4090

Poster Session

Saturday, June 1

1:30 – 4:30 pm

Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2 expressing solid tumors: results from the bladder cohort of DESTINY-PanTumor02 study

P. Wysocki

4565

Poster Session

Sunday, June 2

9:00 am – 12:00 pm

Trastuzumab deruxtecan (T-DXd) in patients with HER2 expressing head and neck tumors: outcomes from DESTINY-PanTumor02

F. Meric-Bernstam

6037

Poster Session

Monday, June 3

9:00 am – 12:00 pm

Datopotamab Deruxtecan (Dato-DXd)

Breast

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable or metastatic hormone receptor positive, HER2 negative breast cancer: Patient-reported outcomes from the TROPION-Breast01 study

S. Pernas

1006

Oral Presentation

Saturday, June 1

3:00 – 6:00 pm

Lung

Datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy as first-line therapy for advanced non-small cell lung cancer: subgroup analysis from TROPION-Lung02

B. Levy

8617

Poster Session

Monday, June 3

1:30 – 4:30 pm

Intracranial efficacy of datopotamab deruxtecan in patients with previously treated advanced/metastatic non-small cell lung cancer with actionable genomic alterations: results from TROPION-Lung05

A. Lisberg

8593

Poster Session

Monday, June 3

1:30 – 4:30 pm

Patritumab Deruxtecan (HER3-DXd)

Pan-Tumor

HERTHENA-PanTumor01: a global, multicohort phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors

A. Bhatia

TPS3164

Poster Session

Saturday, June 1

9:00 am -12:00 pm

Patritumab deruxtecan (HER3-DXd) in active brain metastases from metastatic breast and non–small cell lung cancers, and leptomeningeal disease from advanced solid tumors: the TUXEDO-3 phase II trial

R. Bartsch

TPS2091

Poster Session

Saturday, June 1

9:00 am -12:00 pm

Ifinatamab Deruxtecan (I-DXd)

Lung

IDeate-Lung02: a phase 3, randomized, open-label study of ifinatamab deruxtecan (I-DXd) vs treatment of physician’s choice in relapsed small cell lung cancer

T. Owonikoko

TPS8126

Poster Session

Monday, June 3

1:30 – 4:30 pm

Raludotatug Deruxtecan (R-DXd)

Ovarian

REJOICE-Ovarian01: a phase 2/3 study of raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer

I. Ray-Coquard

TPS5625

Poster Session

Monday, June 3

9:00 am –12:00 pm

DS-3939

Pan-Tumor

A phase 1/2, first-in-human study of DS-3939 in patients with advanced solid tumors: a new DXd ADC targeting TA-MUC1

N. Yamamoto

TPS3165

Poster Session

Saturday, June 1

9:00 am – 12:00 pm

Valemetostat with DXd ADCs

Breast

Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in patients with HER2 low/ultra low/null metastatic breast cancer

T. Iwase

TPS1120

Poster Session

Sunday, June 2

9:00 am – 12:00 pm

Pan-Tumor

A phase 1b, multicenter, open-label study of valemetostat in combination with DXd antibody drug conjugates, trastuzumab deruxtecan (T-DXd) or datopotamab deruxtecan (Dato-DXd), in patients with solid tumors

J. Sands

TPS4180

Poster Session

Saturday, June 1

1:30 – 4:30 pm

About the DXd ADC Portfolio of Daiichi Sankyo
The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

Designed using Daiichi Sankyo’s proprietary DXd ADC Technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.